FDA Device recall Z-0655-2017
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices
- FDA Device
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices by Hologic, citing breach in sterile barrier compromising product sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0655-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-28 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hologic |
| Distribution | US |
Product
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
Reason
Breach in sterile barrier compromising product sterility
Identifiers
| code_info | Lot Code US: 16E25RC 16E25RD 16F16R Lot Code OUS: 16E25RB |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0655-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.